Category Archives: Glucose Monitoring

JPM 2022 Day 1: DXCM, NVS, BAYRY, MDT, TDOC, VRTX; Sanofi Partners with BrightInsight; Viking Initiates GLP-1/GIP Dual Agonist Ph1 Trial

On the first day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Novartis, Bayer, Medtronic, Teladoc, Vertex, Pfizer, Merck, and JNJ. Additionally, two separate cardiometabolic-related news items have been observed: Sanofi announced a partnership with BrightInsight for a digital companion app (potentially for diabetes); and Viking Therapeutics announced the initiation of a Ph1 trial evaluating its novel GLP-1+GIP dual agonist (VK2735). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Senseonics Announces FDA Review for 180-day CGM Nearing Completion; Alnylam and Novartis Announce Collaboration for Liver Failure

Two cardiometabolic-related news items have recently been observed: Senseonics announced updates to its business, including an anticipated PMA supplement approval for its Eversense 180-day CGM “in the coming weeks”; and Alnylam and Novartis announced an exclusive three-year research collaboration to develop an siRNA-based targeted therapy for end-stage liver diseases. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Abbott Announces New Category of Biowearables at CES 2022

During Abbott’s Keynote at CES 2022, Abbott announced plans to develop a new category of consumer Biowearables called “Lingo” designed to help people “understand their body’s unique language” (view Keynote Speech here starting at 1:22:22). These new sensors will separately monitor glucose, ketones, lactate, and alcohol biomarkers to allow patients to make better decisions about general health, nutrition, and athletic performance (view image below). Abbott did not disclose details on the launch timing; however, the company may provide additional context during its upcoming JPM Healthcare Conference presentation on Tuesday, January 11, 2022 at 9:00 AM ET. Below, FENIX provides insights on Abbott’s Lingo platform, including thoughts on how Dexcom’s G7 may be a catalyst for it to also expand into the wellness category.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Medtronic Diabetes Receives FDA Warning; Bigfoot Hires New Senior Leaders; Omada’s mHealth Programs Gain Preferred Status on Evernorth Digital Health Formulary

Three cardiometabolic-related news items have been observed: Medtronic announced it has received a warning letter from FDA on December 9, 2021 for its Diabetes Business headquarters in Northridge, CA; Bigfoot announced the appointment of three new senior leaders; and Omada Health announced that its cardiometabolic digital chronic care programs will be included on the Evernorth Digital Health Formulary. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

vTv Therapeutics to Reduce Workforce by 65%; Innovent Announces Positive Results for Ph1 GLP-1/GCG from Lilly; Nemaura Completes Initial Shipment of CGM Devices to MySugarWatch DuoPack Limited

Three cardiometabolic-related news items have been observed: vTv Therapeutics announced restructuring plans in order to prioritize its Ph3 TTP399 program, including a workforce reduction of 65%; Innovent Biologics announced that results from its Ph1b clinical trial of IBI362 (LY3305677), a dual GLP-1/GCG receptor agonist, for T2DM were presented at the 2021 IDF conference; and Nemaura announced it has completed its initial shipment of sugarBEAT CGM to its UK licensing partner MySugarWatch Limited. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Abbott Sues Dexcom Over Breached Settlement Agreement; Bigfoot Clinical Hub Improvements; Hygieia Raises $17M in Series B; ViaCyte’s Ph1/2 VC-02 Preliminary Results Published; Dario Announces New Employer and Provider Contracts

A series of cardiometabolic-related news items have been observed: Abbott recently filed a lawsuit stating Dexcom allegedly violated a 2014 settlement agreement and asked the court to declare that Abbott doesn’t infringe its patents (view article); Bigfoot Biomedical issued a press release highlighting the success of its Bigfoot Unity Diabetes Management Program and Clinic Hub; Hygieia announced it has raised $17M in Series B financing for its AI-driven d-Nav insulin dose automation technology; ViaCyte announced preliminary results of its ongoing, first-in-human Ph1/2 VC-02 trial were published in Cell Stem Cell and Cell Reports Medicine; and Dario announced new employer and provider contracts. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Sciwind Biosciences Acquires Worldwide Rights to Sanofi’s GIP Receptor Agonists; Diamyd Pauses Initiation of Ph3 DIAGNODE-3 Trial; AMF Medical’s Sigi Patch Pump Receives Breakthrough Device Designation; FDA Authorizes Sample Size Expansion for Fractyl Health’s Revitalize-1 Pivotal Trial

A series of cardiometabolic-related news items have been observed: Sciwind Biosciences announced it has entered into a WW exclusive licensing agreement to develop and commercialize Sanofi’s GIP receptor agonists; Diamyd Medical announced it has paused the initiation of its Ph3 DIAGNODE-3 trial due to potential contamination in the manufacturing process of the Diamyd diabetes vaccine; AMF Medical announced that its insulin patch pump for closed-loop integration (Sigi) has received Breakthrough Device Designation; and Fractyl Health announced FDA authorized the expansion of its Revitalize-1 pivotal clinical study (formerly REVITA-T2Di) sample size from 288 to 420. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Libre 2 Android App Cleared in US; CytoDyn Reports Positive Leronlimab NASH Data; Kadimastem Raises $3.2 to Support T1DM Cell Therapy Development; Integrity Applications Changes Name to GlucoTrack, Inc.

A series of cardiometabolic-related news items have been observed: It has been observed that the Libre 2 Android app recently received FDA clearance (view FDA 510(k) database); CytoDyn announced positive data from the leronlimab open-label NASH trial; Kadimastem announced it has raised $3.2M from ILEX Medical in a private financing round to support Kadimastem’s T1DM and ALS cell therapy development programs; and Integrity Applications announced it has changed its name to GlucoTrack, Inc. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Medtronic CY Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. Below, FENIX provides highlights and insights for the respective new items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.